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IRCT20141209020250N3 IRCT 2018-06-19 Tehran University of Medical Sciences Effect of intralesional injection of rituximab in recalcitrant pemphigus lesions. Evaluation of the efficasy of intralesional rituximab injection for remision of recalcitrant lesions in the patients with pemphigus vulgaris. 2018-08-23 anticipated 20 Complete https://irct.ir/trial/29235 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment, Other design features: quazi-experimantal. 2 pemphigus vulgaris. Intervention group: for 15 patient with mucocutaneous recalcitrant lesion of pemphigus vulgaris , we will prescribe intralesional injection of rituximab with dose of 5 mg/cm2 ( 0/5 cc per 1 cm2 of lesion ) , we will take patients stat dose of hydrocortisone 100 mg , chlorpheniramin and acetaminophen 500 mg before of injection and we will follow them for 6 months.. Yes - There is a plan to make this available What will be shared: All data including age, sex, duration of illness, drugs used by the patient, amount and duration of taking corticosteroid and immunosuppressive, history of rituximab injection, duration of previous injection of rituximab, complications of intra-lesion injection of rituximab, severity of complications, severity of disease and satisfaction and score of Quality of life, The changes in desmagolin levels 1 and 3, and changes in levels of CD4 and CD19 cell count will be released. When: As soon as completion of the study and analysis of the data, the results will be available to the researchers. To whom: All investigators , students , doctors and, in general, people working in the field of autoimmune bullous disorders. Conditions: To achieve a safe and low-cost effective treatment protocol for patients with pemphigus vulgaris who suffer from recalcitrant mucosal lesions. Where to obtain: Dept. of Research and Technology of Tehran University of Medical Sciences and Autoimmune bullous Disorders Research Center and Iranian Record of Clinical Trial website How to obtain: Login to Autoimmune Bullous Disorders Research Center and Iranian Record of clinical trial Center Comments:
public EBRAHIM MAZLOOM
No 1, bakhshandegan Avenue, Valiasr BLV,Tehran
Tehran Iran (Islamic Republic of) 1516744163 +98 21 8820 8156 hanymazloom@yahoo.com Tehran University of Medical Sciences scientific Narges Ghandi
District 12, vahdate eslami square, Razi hospital
Tehran Iran (Islamic Republic of) 1199663911 +98 21 5563 0553 nghandi@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) suffering from pemphigus vulrais, confirmed by clinical, histoligical and immunological criteria. Skin or mucosal lesions with maximum diameter of 6 cm or 20 cm2 which are recalcitrant (means continued development of new lesions, continued extension of old lesions, or failure of established lesions to begin to heal despite 3 weeks of therapy on 1.5 mg/kg/d of prednisone equivalent with or without any of the following agents: cyclophosphamide 2 mg/kg/d for 12 weeks; azathioprine 2.5 mg/kg/d for12 weeks (if thiopurine s-methyltransferase level is normal); methotrexate 20 mg/wk for 12 weeks; or mycophenolate mofetil 3 g/d for 12 weeks.). Insufficient response to three times intralesional injection of triamcinolone acetonide or topical super potent corticosteroid for at least 1 month. no new lesion in recent 12 weeks. no cardiac or infectious contraindication to rituximab. oral steroid usage of <= 20 mg/d. no limit no limit Both Patients with active lesions (expansion of previous old lesions or new lesions in recent 12 weeks). Contraindications to rituximab (including hepatitis B, hepatitis C, progressive neurologic disease, angina, arrhythmia, herpes virus infection, CMV infection, acute pneumonia, renal diseases, lactation, hyperphosphatemia, hypocalcemia, hyperkalemia, anemia, low platelet or leukocyte count. Injection of intravenous rituximab in recent 6 months. L10.0 Pemphigus vulgaris Treatment - Drugs Intervention group: for 15 patient with mucocutaneous recalcitrant lesion of pemphigus vulgaris , we will prescribe intralesional injection of rituximab with dose of 5 mg/cm2 ( 0/5 cc per 1 cm2 of lesion ) , we will take patients stat dose of hydrocortisone 100 mg , chlorpheniramin and acetaminophen 500 mg before of injection and we will follow them for 6 months. Anti desmogline 1. Timepoint: baseline , 3 months , 6 months later. Method of measurement: blood sampling. Anti desmogline 3. Timepoint: baseline , 3 months , 6 months. Method of measurement: blood sampling. CD4 cell count. Timepoint: baseline , 15 day and 1 month later. Method of measurement: blood sampling. CD19 cell count. Timepoint: baseline , 15 day and 1 month later. Method of measurement: blood sampling. Disease severity. Timepoint: before intervention and 1, 3, 6 months after intervention. Method of measurement: Pemphigus Disease Area Index (PDAI ). Patient satisfaction. Timepoint: baseline, 1 month , 3 month , 6 month later. Method of measurement: Visual analyze scale. Quality of life. Timepoint: baseline, 1 month , 3 month , 6 month later. Method of measurement: pemphigus quality of life questioner. Size of lesion. Timepoint: baseline, 15 days , 1 month , 3 month , 6 month later. Method of measurement: ruler. Tehran University of Medical Sciences Approved 2018-03-07 Tehran University of Medical Sciences Ethics committee Tehran University of Medical Sciences, Office of Vice Chancellor for Research and Technology, 6th floor, Ghods Street, Keshavarz Boulevard Tehran Tehran Iran (Islamic Republic of)